HospitalInspections.org

Based on record review and interview, the facility failed to demonstrate compliance with CMS (Centers for Medicare and Medicaid Services) memo QSO-22-07-ALL, the interim final rule which established requirements regarding COVID-19 vaccine immunization of staff, in 1 of 1 infection control program reviewed. This failure has the potential to affect all patients, staff and visitors; putting all at risk for COVID-19 exposure and illness.

Findings include:

The facility failed to ensure policies and procedures addressed contingency plans and additional precautions for unvaccinated staff. See Tag A-0792.

The facility failed to ensure policies and procedures addressed established criteria for determining medical exemption eligibility based on recognized clinical contraindications. See Tag A-0792.

The facility failed to ensure policies and procedures addressed established criteria for determining eligibility for staff whose vaccination status must be temporarily delayed. See Tag A-0792.

The facility failed to ensure that a process for tracking, monitoring, and documenting the vaccination (and/or exemption) status for all staff was in place for 2 of 6 staff categories (Contracted Independent Licensed Practitioners; Contracted facility staff). See Tag A-0792.

Based on record review and interview, the facility failed to ensure that a process for tracking, monitoring, and documenting the COVID-19 vaccination (and/or exemption) status for all staff who are employed at the facility was in place for 2 of 6 staff categories (Contracted Independent Licensed Practitioners; Contracted facility staff), and failed to ensure that the policy developed regarding COVID-19 vaccination addressed the required minimum components in 1 of 1 COVID vaccination program reviewed.

Findings include:

A review of the facility's policy #10702259 titled, "Patient and Health Care Personnel Safety-COVID 19 Vaccine Policy 2021-2022," last revised 11/08/2021 revealed," ...Ascension Wisconsin requires all members of the workforce to receive the COVID-19 vaccination ...Workforce: This includes employed associates, including those employed by subsidiaries and partners; physicians and advanced practice providers, whether employed or independent; medical students and residents; and students, faculty, volunteers entering Ascension facilities who are required to receive a COVID-19 vaccination. Exemption Review Committee (ERC): A multidisciplinary team charged with reviewing requests for medical and/or religious exemption. The ERC generally includes representatives from Human Resources, Ethics, Mission Integration, Infection Prevention and Control, and Associate and Occupational Health ...As a condition of employment, providing services in any program or capacity on our premises, performing clinical rotations, or initiation and/or maintenance of medical staff privileges and membership, all workforce members are required to receive COVID-19 vaccinations unless exempt for medical or religious reasons. Volunteers must also comply ...and are not eligible for exemptions ...All associates shall have until November 12, 2021 to comply with COVID-19 vaccination requirements ...Workforce members who have not complied by November 12, 2021 ...will be suspended pending further investigation ...For non-employed workforce, ongoing failure to comply may result in their removal from the premises and/or cessation of services ...Medical exemption requests must include supporting medical documentation signed by a licensed healthcare provider who is providing ongoing medical care for the associate. The documentation must include information articulating the nature of the health condition that the treating provider considers a contraindication to the COVID-19 vaccine. Requests for exemption are individually reviewed by the ERC. The exemption determination will be communicated to the associate and direct supervisor via email. If a granted exemption is deemed permanent, subsequent submissions are not required. If a granted exemption is deemed temporary, the workforce member must resubmit exemption requests annually ..."

Further review of the policy revealed no evidence of documented additional precautions or contingency plans for unvaccinated workers. There was no evidence found regarding defined criteria for staff's eligibility for a medical exemption or temporary delay according to recognized clinical contraindications.

During an interview on 02/02/2022 at 1:45 PM, when asked about contingency plans or additional precautions for unvaccinated workers, Quality Director D stated, "We are continuing universal source control and social distancing. We are not instituting testing at this time."

During an interview on 02/03/2022 at 10:15 AM, when asked about contingency plans or additional precautions for unvaccinated workers, Director of Infection Prevention H stated, "We are not doing anything additional at this time. We are still requiring universal source control, symptom tracking; we have N95s (respirators) available for those who want it."

During an interview on 02/03/2022 at 10:25 AM, when asked about the additional precautions for unvaccinated staff as outlined in the QSO-22-07-ALL memo, Quality Coordinator C stated, "We interpreted those [additional measures] as recommendations, not requirements."

During an interview on 02/03/2022 at 11:14 AM, when asked about the medical exemption criteria and how those were approved, Manager of Associate Health I stated, "Associates fill out the request online. They go directly to National. A team there reviews and approves all religious and medical exemptions. We don't see the requests at a local (facility) level." Manager I stated that s/he did not know what criteria the "National team" used to determine medical exemption approval or denial. Manager I stated, "We (Associate Health) just get a notification that an associate has an approved exemption. We don't know the details."

During a review of facility staff lists, it was determined that multiple services provided at the facility were contracted with different vendors, including food service, environmental services, facilities and maintenance, registration and billing, and biomedical services, in addition to contracted independent licensed practitioners with hospital privileges.

During a review of facility documentation of COVID-19 vaccination, there was a total of 233 contracted facility staff. There was a total of 215 staff with documentation of completion of the vaccine or approved exemptions (92.3%).

During a review of facility documentation of COVID-19 vaccination, there was a total of 1,038 Contracted Independent Licensed Practitioners. There was a total of 933 practitioners with documentation of completion of the vaccine or approved exemptions (89.9%).

During an interview on 02/03/2022 at 11:35 AM, Manager of Associate Health I stated the facility's Associate Health team was responsible for tracking and monitoring the vaccination status of employed and agency staff and students and volunteers only. Manager I stated that the individual leaders of the contracted services were responsible for tracking, monitoring, and following up with their direct reports. Manager I stated, "There is not a current process for contracted services to report compliance or tracking (of vaccination status) to the organization."

During an interview on 02/03/2022 at 11:39 AM, Quality Director D stated, "There is not currently a defined process for tracking medical staff compliance [with the vaccination status requirement]." Director D stated that the facility had not yet determined which department or individual(s) would be responsible for tracking and monitoring the vaccination status of and following up with the contracted independent licensed practitioners.

During a review of facility documentation of COVID-19 vaccination, there was a total of 2,969 Employees, Students, Volunteers, Agency staff, Contracted facility staff, and Contracted Independent Licensed Practitioners. There was a total of 2,846 staff with documentation of completion of the vaccination or approved exemptions (95.9%).